Events

Rappel de PARADIGM QUICK-SET INFUSION SETS

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par MEDTRONIC OF CANADA LTD..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    18735
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2013-06-13
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notes supplémentaires dans les données
  • Cause
    Medtronic has become aware of a potential safety issue that can occur if insulin or other fluids come in contact with the inside of the connector on medtronic paradigm infusion sets. this recall also provides information on how to prevent this from occurring. exposure of the inside of the tubing connector to fluid is most likely to occur if insulin is spilled on the top of the insulin reservoir when the reservoir is removed from the transfer guard after filling the reservoir from a vial of insulin. if this occurs the insulin can temporarily block the vents in the connector that allow the pump to properly prime. if these vents are blocked this can potentially result in too much or too little insulin being delivered which may cause hypoglycemia or hyperglycemia which in extreme cases may cause loss of consciousness or death.

Device

PARADIGM QUICK-SET INFUSION SETS
  • Modèle / numéro de série
    Model Catalog: MMT-396600 (Lot serial: All lots contact manf); Model Catalog: MMT-386600 (Lot serial: All lots contact manf); Model Catalog: MMT-387600 (Lot serial: All lots contact manf); Model Catalog: MMT-394600 (Lot serial: All lots contact manf); Model Catalog: MMT-397600 (Lot serial: All lots contact manf); Model Catalog: MMT-398600 (Lot serial: All lots contact manf); Model Catalog: MMT-399600 (Lot serial: All lots contact manf); Model Catalog: MMT-874 (Lot serial: All lots contact manf); Model Catalog: MMT-864 (Lot serial: All lots contact manf); Model Catalog: MMT-862 (Lot serial: All lots contact manf); Model Catalog: MMT-840 (Lot serial: All lots contact manf); Model Catalog: MMT-379 (Lot serial: All lots contact manf); Model Catalog: MMT-380 (Lot serial: All lots contact manf); Model Catalog: MMT-377600 (Lot serial: All lots contact manf); Model Catalog: MMT-384600 (Lot serial: All lots contact manf); Model Catalog: MMT-378600 (Lot serial: All lots contact manf); Model Catalog: MMT-368600 (Lot se
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Description du dispositif
    PARADIGM QUICK-SET INFUSION SETS
  • Manufacturer
    MEDTRONIC OF CANADA LTD.

Manufacturer

MEDTRONIC OF CANADA LTD.
  • Adresse du fabricant
    BRAMPTON
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    HC